Clinical Efficacy and Safety of the New Cardioverter Defibrillator Systems

Clinical efficacy and safety of two new third-generation implantable cardioverter defibrillators (ICD) were studied in 38 patients with ventricular tachycardia (VT) or fibrillation (VF). There were 31 patients with coronary disease, three patients with right ventricular dysplasia, one patient with dilated cardiomyopathy, and three patients with valvular disease. Twenty-four patients (group I) received an ICD with monophasic (Ventak PRx 1700, CPI) and 14 patients (group II) with biphasic shocks (Cadence V 100, Ventritex). Intraoperatively, the mean defibrillation threshold was significantly lower in group II than in group I, both in patients with induced VT (group I 11.0 ± 6.3 joules: group N 5.8 ± 1.3 joules) (P < O.01) and induced VF (group I 17.5 ± 4.6 joules; group II 9.6 ± 5.2 joules) (P < O.O1). During the mean follow-up of 12 ± 7 months four patients (11%) died. 865 arrhythmia events (AE) occurred and were terminated by ATP (671 VTs, 78%). Acceleration of VTs was observed in 28 AE (3%) and ATP was unable to interrupt 58 AE (7%). ICD shocks were delivered as a first therapy in 108 AE (13%).     

Initial Experience with a New Transvenous Defibrillation System

The clinical efficacy and safely of a new bidirectional transvenous defibrillation endocardial lead system (ELS) was studied in 39 patients with ventricular tachycardia (VT) or fibrillation (VF). There were 28 patients with coronary disease and 11 patients with nonischemic VT/VF. Fourteen patients received the ELS combined with antitachycardia pacing devices (Ventak PRx 1700, CPI) and 25 patients with the Ventak P or P2 (CPI). Implantation of the ELS was attempted in 47 patients. Intraoperatively, the mean defibrillation threshold (DFT) was > 25 joules in five patients and no reliable ELS position was found in three other patients. These eight patients underwent thoracotomy and epicardial leads implantation. The mean DFT was ≤ 20 jouJes in all 39 patients and the mean DFT was 18 joules. During the mean follow-up of 8 ± 2 months two patients (5%) died suddenly. Complications occurred in two patients (5%).     

Transvenous Defibrillation Leads: Is There an Ideal Position of the Defibrillation Anode?

A potential benefit of two-lead transvenous defibrillation systems is the ability to independently position the defibrillation electrodes, changing the vector field and possibly decreasing the DFT, Using the new two-lead transvenous TVL lead system, we studied whether DFT is influenced by SVC lead position and whether there is an optimal position. TVL leads and Cadence pulse generators were implanted in 24 patients. No intraoperative or perioperative complications were observed. In each patient, the DFTs were determined for three SVC electrode positions, which were tested in random order: the brachiocephalic vein, the mid-RA, and the RA-SVC junction. The mean DFTs in the three positions were not statistically different, nor was any single lead position consistently associated with lower DFTs. However, an optimal electrode position was identified in 83% of patients, and the DFT from the best lead position for each patient was significantly lower than for any one of the electrode positions (P < 0.01). The mean safety margin for the best SVC lead position was approximately 27 J. These results demonstrate the advantage of a two-lead system, as well as the importance of testing multiple SVC lead positions when the patient's condition permits. Both of these factors can decrease the DFT and maximize the defibrillation safety margin. This will become increasingly important as pulse generator capacitors become smaller (as part of the effort to decrease generator size) and the energy output of the generators consequently decreases.     

Epicardial and Nonthoracotomy Defibrillation Lead Systems Combined with a Cardioverter Defibrillator

The intraoperative and long-term results were reviewed in 67 patients who underwent implantation of the Ventritex Cadence defibrillator with either epicardial patch (EPI, 25 patients) or nonthoracotomy CPI Endotak (ENDO, 42 patients) defibrillation lead systems. In the ENDO group, 35 patients (83 %) had a defibrillation threshold (DFT) of ≤ 20 joules and did not require a subcutaneous patch. Intraoperatively, the DFT was 13 ± 9 joules (mean ± SD) for EPI and 15 ± 8 joules for ENDO (P = NS). There was no perioperative death in either group. During a mean follow-up of 12 ± 8 months, there was no sudden death, and four patients died from congestive heart failure (3 EPI, 1 ENDO). During follow-up, 875 spontaneous arrhythmia episodes (AE) occurred in 15 of 25 EPI patients (60%). versus 652 in 28 of 42 ENDO patients (67%; P = NS). Ventricular tachycardia at a rate ≥ 222 beats/min or ventricular fibrillation represented 167 AE for EPI (19%) and 182 AE for ENDO (28%), and was terminated by the first shock in 76% and 75% of attempts, respectively. Ventricular tachycardia at a rate ≥ 222 beats/min represented a total of 1,178 AE and antitachycardia pacing was successful in 660 of 708 AE (93%) with EPI and 414 of 470 AE (88%) with ENDO lead systems (P= NS). Therefore, a nonthoracotomy approach using the Cadence V-100 is safe and effective and has clinical results that are not significantly different from epicardial defibrillation lead systems.     

Nonpharmacological Therapy of Ventricular Tachyarrhythmias: Observations in 554 Patients

It has been shown that conventional antiarrhythmic drug treatment is debatable, and there is growing interest in nonpharmacological techniques. We studied the outcome of 554 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) who underwent nonpharmacological techniques from March 1980 to June 1994 at our institution. Catheter ablation was performed in 51 patients (G1), map guided surgery in 147 (G2), and cardioverter defibrillator implantation (ICD) in 356 (C3). During a mean follow-up of 37 ± 12 (< 1–137) months, incidence of sudden death (G1 4%, G2 6%, C3 3%) and cardiac death (G1 7%, G2 16%, G3 8%) were relatively low, and there was no significant differences between G1-G3. VT/VF recurrences occurred more frequently in G1 (57%) than in G2 (18%) (P < 0.01). ICD discharges occurred in 69% of patients. We conclude that nonpharmacological techniques lead to low sudden death rates; however, there is a high rate of recurrence in G1. Risk stratification is necessary to select the ideal therapy for each individual patient.